FeMoropopliteal AngioSculpt™ SCoring BallOon CaTheter Study (MASCOT)

Prospective, Multicenter, Non-randomized Clinical Trial Investigating the Safety and Efficacy of the AngioSculpt Scoring Balloon Catheter (AngioScore, Inc.) for the Treatment of Femoropopliteal Stenotic Disease.

This investigation is designed to demonstrate the efficacy and safety of the 4.0-5.0mm AngioSculpt Scoring Balloon Catheter (AngioScore, Inc.) for femoropopliteal use in a controlled clinical investigation.

The scoring balloon is a semi-compliant balloon encircled by 3 spiral struts with a nitinol scoring element, which theoretically provides targeted scoring of lesions, by concentrating the dilation force thus minimizing barotrauma, elastic recoil and uncontrolled dissection. This may improve the outcome of the intervention and reduce the number of stents required.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Occlusive Disease
• Intervention / Treatment: Device: 4.0-5.0mm AngioSculpt Scoring Balloon Catheter

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Bonheiden, Belgium, 2820
    • Imelda Hospital
  • Dendermonde, Belgium, 9200
    • AZ St-Blasius
• Germany
  • Leipzig, Germany, 04289
    • Herzzentrum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Stenotic (>50%) or occlusive atherosclerotic disease of the femoropopliteal arteries (primarily superficial femoral arteries - SFA)
• Length of lesion >5 cm or 2 times the AngioSculpt balloon length (whichever is longer)
• Reference vessel diameter should be 4.0-6.0 mm
• Life altering claudication or critical limb ischemia (Rutherford 3-5)
• No untreated inflow-limiting arterial lesions
• At least single vessel run-off until the ankle
• The patient must be > 18 years.
• Life-expectancy of more than 12 months
• The subject or legal guardian has been informed of the nature of the evaluation; agrees to its provisions and has signed informed consent
• The patient is capable to follow all evaluation requirements.

Exclusion Criteria:

• Patient refusing treatment
• The reference segment diameter is not suitable for available catheter design
• Length of lesion is ≥5 cm or requires more than two overlapping AngioSculpt balloon inflations (whichever is longer) to cover the entire lesion (however, more than two inflations are permitted within an acceptable lesion length)
• The patient has a known allergy to heparin, aspirin or other anticoagulant/antiplatelet therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies
• The patient has a history of prior life-threatening contrast media reaction
• The patient is currently enrolled in another investigational device or drug trial
• The patient is currently breast-feeding, pregnant or intends to become pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Patients receiving 4.0-5.0mm AngioSculpt Scoring Balloon Catheter (AngioScore, Inc.) for femoropopliteal use	Device: 4.0-5.0mm AngioSculpt Scoring Balloon Catheter; The AngioSculpt Scoring Balloon Catheter is a line of innovative angioplasty catheters comprising an angioplasty balloon surrounded by a unique system of nitinol scoring elements. Creating focal concentrations of dilating force, the scoring elements score arterial lesions as the balloon expands.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Complication Free Survival at 1 month post-procedure (complications = major amputations defined as amputations at or above the ankle, any cause of death and TLR)	1 month

Secondary Outcome Measures

Outcome Measure	Time Frame
patency of the target lesion. Primary patency is defined as the absence of: a) target lesion revascularization (TLR); b) major amputation due to lesion restenosis or occlusion; c) conversion to bypass surgery and d) untreated significant stenosis on CFDU	12 months

Collaborators and Investigators

• Sponsor: Flanders Medical Research Program
• Collaborators: AngioScore, Inc.
• Investigators: Principal Investigator: Patrick Peeters, MD, Imelda Hospital, Bonheiden, Belgium

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): November 1, 2008
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: February 7, 2008
• First Submitted That Met QC Criteria: February 7, 2008
• First Posted (Estimate): February 21, 2008

Study Record Updates

• Last Update Posted (Estimate): July 5, 2010
• Last Update Submitted That Met QC Criteria: July 2, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases
• Other Study ID Numbers: FMRP-003